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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036578
Receipt No. R000041526
Scientific Title Study 3 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function
Date of disclosure of the study information 2019/04/26
Last modified on 2019/05/28

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Basic information
Public title Study 3 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function
Acronym Study 3 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function
Scientific Title Study 3 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function
Scientific Title:Acronym Study 3 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study was to investigate the effects of continuous intake of test foods for 12 weeks on cognitive function of Japanese men and women who are aware of decline in cognitive function when they are 50 years of age or older and 69 years of age or younger.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognitrax,MMSE
Key secondary outcomes Pittsburgh Sleep Quality Index
Uchida-Klepelin test
Brain-derived neurotrophic factor
Amyloid-beta (1-40, 1-42)
Secreted Amyloid Precursor Protein-alpha
Amyloid Precursor Protein 770
MicroRNA

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 12-week intake of the test food1
Interventions/Control_2 12-week intake of the test food2
Interventions/Control_3 12-week intake of the placebo food
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria 1) Japanese men and women aged 50 to 69 years at the time of informed consent
2) Subject who is aware of cognitive decline
3) Subject who is able to take 3 capsules daily for 12 weeks.
4) Subject with an MMSE score of 24 or more
5) Non smoker
6) Subject who has received sufficient explanation of the purpose and content of the research, is capable of giving informed consent, voluntarily volunteers to participate in the research, and consents to participate in the research in writing.
Key exclusion criteria 1) Subject who is currently receiving any medications or outpatient treatment.
2)Subject who is currently doing exercise or diet under the supervision of a doctor
3)Subject who is may develop allergy due to the test food
4)Subject who is drug dependent, present or dependent on alcohol
5) Subject who is history of psychiatry during hospitalization due to mental disorder (depression etc.) or sleep disorder (insomnia, sleep apnea syndrome etc.)
6)Night shift or shift workers
7) Excessively irregular lifestyle such as eating or sleeping
8) Subject who is extreme skipped eating
9)Subject who is current disease or history of diabetes, liver disease (hepatitis), kidney disease, serious disease such as heart disease, thyroid disease, adrenal disease, other metabolic diseases
10)Subject who is use health foods, supplements, and medicines that may affect cognitive function
11) Subject who is participated in other human clinical studies within the past 3 months or are expected to participate in other human clinical studies during the study period.
12)Subject who is carried out blood collection, component blood donation more than 400 mL within 200 mL or 3 months within one month going back from the date of consent acquisition
13) Subject who is pregnant, breast-feeding, or willing to become pregnant during the study period
14)Subject who is difficult to comply with the records of various surveys
15)Subject who is judged to be unsuitable as subject from clinical laboratory test value and measurement value at the time of SCR
16)Other than the above, the principal investigator judged that the subject was ineligible for the study.
Target sample size 51

Research contact person
Name of lead principal investigator
1st name Takanobu
Middle name
Last name Takihara
Organization ITOEN,Ltd.
Division name Central Research Institute
Zip code 421-0516
Address 21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
TEL 0548-54-1247
Email t-takihara@itoen.co.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Ochitani
Organization HUMA R&D CORP
Division name Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014
Zip code 108-0014
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014
TEL 81-3-3431-1260
Homepage URL
Email ochitani@huma-rd.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization ITOEN,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committees of Nihonbashi Egawa Clinic
Address 2F Kotobuki Build. 1-27-12 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel 03-5204-0311
Email jim@medipharma.co.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2019 Year 03 Month 08 Day
Date of IRB
2019 Year 03 Month 11 Day
Anticipated trial start date
2019 Year 05 Month 07 Day
Last follow-up date
2019 Year 09 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 23 Day
Last modified on
2019 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041526

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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